Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01823133

Enrollment

Registered

2013-04-04

Start date

2013-04-30

Completion date

2013-08-31

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects

Interventions

DRUGgemigliptin only

gemigliptin 50mg qd on day 1\ 7

DRUGrosuvastatin only

rosuvastatin 20mg qd on day 1\ 7

DRUGgemigliptin and rosuvastatin

gemigliptin 50mg, rosuvastatin 20mg qd on day 1\ 7

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 20 to 45, healthy male subjects (at screening) * BMI between 18 - 27 kg/m2 (at screening) * Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg * FPG 70-125mg/dL glucose level (at screening) * Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the

Exclusion criteria

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.) * Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included) * Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics) * Subject who already admitted in other investigator product in 80 days * Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently

Design outcomes

Primary

Measure	Time frame	Description
Cmax	up to 72 hour post dose	to evaluate Cmax of gemigliptin and rosuvastatin at steady state
AUC	up to 72 hour post dose	to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state

Secondary

Measure	Time frame	Description
t1/2β	upto 72 hour post dose	to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
Cmax	upto 72 hour post dose	to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Tmax	up to 72 hour post dose	to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
metabolic ratio	upto 72 hour post dose	to evaluate metabolic ratio of gemiglipin and rosuvastatin
AUC	upto 72 hour post dose	to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Cmin	upto 72 hour post dose	to evaluate Cmin of gemigliptin and rosuvastatin at steady state

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026